What mistakes are most likely to keep my IRB Protocol from being approved? The IRB looks at all aspects of your protocol application and may have questions on any part of it that need to be cleared up prior to approval. However, there are several common problems that postpone approval. These are discussed in the following "Hints on Writing a Strong IRB Protocol Application":
- Project dates must reflect when the actual interaction with research participants will occur. The start date CANNOT be a date prior to submission date. IRB protocols must remain open as long as you are using human subject data; this includes data analysis.
- The abstract and methods sections MUST be written in layman's terms. Though the committee is diverse and well educated both formally and informally, it is possible that they are not familiar with the particular research that is being reviewed. Avoid the use of technical or field specific jargon and acronyms whenever possible. If you absolutely need to use jargon or acronyms, define them the first time each is used.
- The Principal Investigator MUST read and sign the PI Assurance on the first page. This a binding commitment from the PI that human subject protection is a cornerstone of the research being proposed. The original (first page only) with signature must be sent to the Office of Research Integrity.
- Tenured, tenure-track and emeritus faculty may serve as a PI. Other University personnel may serve as the PI as specified in the PI eligibility policy. Doctoral and Graduate students may not be PIs, but must be listed in the personnel and qualifications section of the application if they will have access to identifiable human subjects' data.
- When completing the personnel & qualification section provide the Board with information that validates expertise to conduct the type of research being proposed. A medical doctor that specializes in the care of children would not be considered qualified to conduct open heart surgery on a adult or even a child for that matter unless the doctor had successfully attained that level of expertise and specialization. It would be very appropriate for the doctor to have a cardiac specialist on the care team if the child had heart problems. Although it is not typically a life or death issue for social research, the IRB has similar expectations in that at least one person with expertise in the subject area or with the community that is the subject of the research should be included on the research team.
- When providing the IRB with information about the literature review, remember the IRB is looking for information related to process or methodolgies to be used in the proposed research. The Board is interested in knowing that the techniques to be used are up to date as well as that the work does not unnecessarily duplicate prior work and that the research is a good use of the research participants time (i.e. that the potential benefits outweight the costs/risks of participating in the research).
- If the research population includes participants under 18 years of age you must discuss why this is important or necessary. The human subjects regulations require special protections/considerations for research participants under the are of 18 years old. If all of the research participants will be adults (18 years of age or older) you must explicitly state that minors will be excluded from the proposed research.
- If the intended participants may not speak English fluently or speak English as second language you must state how you will address challenges related to language comprehension, whether written, oral, or both. You must i dentify in the IRB protocol application how you will deal with survey/interview and informed consent issues that may be encountered. The IRB may require that you obtain the services of a translator or have the participant information available in the native language of the participants to insure consent is truly informed and voluntary. Alternatively, you may elect to limit participation to individuals who are fluent in English.
- If there is concern about literacy of the research population a plan to address the needs for informed consent and validation of proposed research tools needs to be fully discussed in the application. For example, it may be appropriate to utilize an oral consent process or one that combines an oral disclosure/discussion with a written summary. Likewise, use of written or web-based survey tools may be inappropriate.
- If the research is to be conducted in a private residence or place of business be sure to discuss fully why this is appropriate and necessary. While the primary function of the IRB is the protection of research participants the Board also remains aware of safety issues for the researchers as well, particularly student researchers.
- Consent / Assent forms must be written at an age appropriate level, however, the level should not exceed an eighth grade reading level unless it is specifically justified in the protocol. The average adult population reads at between an 6th and 8th grade reading level. The spelling and grammar check feature in most word processing packages will provide a rudimentary assessment of a document's reading level. However, please be aware that these features provide a fairly crude evaluation and therefore should be used as a guide only. The IRB recognizes that occasionally researchers need to use words or phrases that exceed the recommended reading level; when this occurs you must specify which words or phrases are responsible. Defining "problem" words the first time they are used may eliminate potential comprehesion difficulties; but in other cases, the IRB may find that the use of the "problem" words or phrases cannot be avoided and is appropriate given the nature of the research.
- Consent / Assent forms that will be used for projects subject to expedited or full board review must contain the core components outlined in the consent examples. However, the IRB may waive some or all of the informed consent components or the requirement for written documentation in specific circumstances. If you would like more information on when this is an option, please contact the Office of Research Integrity. Research that is "exempt" does not have the same informed consent requirements and may be handled in a simplified fashion, for example, a survey that is mailed to participants and does not require any identifying information may simply have a statement at the top stating why the survey is being conducted and that participation is voluntary. However, the Office of Research Integrity encourages all researchers to provide their contact information (official UAF contacts are stronly recommended) and that of the IRB so that participants can ask questions, report concerns, etc.